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Advanced Solid TumorPhase 1NCT04805307

Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy, Phase 1 Study of CMG901

A Phase 1 study testing CMG901 in people with Advanced Solid Tumor and Gastric Cancer(Including Gastroesophageal Junction Adenocarcinoma), run by Keymed Biosciences Co.Ltd at 32 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multi-center, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of CMG901. The dose escalation phase (Part A) will determine the MTD of CMG901 in subjects with relapsed and/or refractory advanced solid tumor for which… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
CMG901
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
32 sitesChina
Study dates
24 Dec 2020to 5 Apr 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with histologically or cytologically confirmed advanced solid tumors, who have failed to respond to standard of care (progression after treatment or intolerance) or who have no available standard of care regimen.
  • Part A: Must provide archival tumor tissue specimen or agree to undergo a fresh biopsy if archival specimen is unavailable for retrospective Claudin 18.2 testing prior to enrollment;Subjects enrolled in Part A are not required to be positive for Claudin 18.2.
  • Part A: Measurable or evaluable lesions per RECIST v 1.1.Part B: At least one measurable lesion per RECIST v1.1.
  • Part B: Subjects shall provide fresh or archival tumor tissue samples before enrollment for assessment of Claudin 18.2 expression level (central laboratory) and should be positive for Claudin 18.2 as determined by the central laboratory. If the subject can provide positive Claudin 18.2 expression results which had been reported by the same central laboratory using the same method, there is no need for another test.
  • Women of childbearing potential and male subjects must agree to remain abstinent or use contraceptive methods as defined by the protocol.
  • Eastern Cooperative Oncology Group Performance Status 0-1.
  • Side effects of any prior therapy or procedures for any medical condition has recovered to NCI-CTCAE v.5.0 Grade ≤ 1 or stable status by investigator.

Who cannot join

  • Received: chemotherapy or any investigational anti-tumor agents within 28 days of the start of CMG901 treatment; molecularly-targeted agents, immunoconjugate, or antibody drug conjugate within 28 days or or 5 half-lives (whichever is shorter) of the start of CMG901 treatment; major surgery within 28 days of the start of CMG901 treatment; radiotherapy within 21 days of the start of CMG901 treatment; potent cytochrome P450 3A4 (CYP3A4) inhibitors within 14 days or or 5 half-lives (whichever is longer) of the start of CMG901 treatment.
  • Diagnosis of immunodeficiency or requiring another form of chronic immunosuppressive therapy. Or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone or equivalent) within 7 days prior to the first dose.
  • History of severe hypersensitivity to any component or excipient of CMG901.
  • Ongoing or active infection or interstitial pneumonia assessed by investigator.
  • Any severe cardiac dysfunction including left ventricular ejection fraction <50%, congestive heart failure ≥Grade 2 (New York Heart Association), QTc >480 msec, major cardiovascular and cerebrovascular diseases (e.g., congestive cardiac failure, acute myocardial infarction, unstable angina, stroke, transient ischemic attack, deep vein thrombosis or pulmonary embolism) within 6 months prior to the first dose of study drug.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Show all 11Show fewer
  • Subjects with uncontrolled ascites, pleural effusion, or pericardial effusion by investigator.
  • Preexisting sensory and/or motor neuropathy Grade ≥2.
  • Uncontrolled diabetes mellitus or diabetic neuropathy within 3 months of the first dose of CMG901.
  • Subjects with active hepatitis B or C, i.e., positive for anti-HCV antibody and positive for HCV RNA, or positive for HBsAg with detectable positive for HBV DNA (i.e., ≥ 2000 IU/mL).
  • Any other conditions such as medical history, treatment, laboratory abnormalities that may confound the study results, interfere with the subject's compliance, or impair the interests of the subject, as assessed by the Investigator.

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

China32 sites

  • Affiliated Hospital of Hebei University

    Baoding

  • Hunan Cancer Hospital

    Changsha

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • Sichuan Cancer Hospital

    Chengdu

  • Chongqing University Cancer Hospital

    Chongqing

  • Fujian Cancer Hosppital

    Fuzhou

  • Fujian Medical University Union Hospital

    Fuzhou

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou

  • Sun Yat-sen University Cancer Center (SYSUCC)

    Guangzhou, Guangdong

  • Guangdong Provincial People's Hospital

    Guangzhou

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou

  • Hainan General Hospital

    Haikou

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou

  • Harbin Medical University Cancer Hospital

    Harbin

  • The Second Hospital of Anhui Medical University

    Hefei

  • Affiliated Hospital of Jining Medical University

    Jining

  • Lanzhou University Second Hospital

    Lanzhou

  • The First Affiliated Hospital of Henan University of science and Technology

    Luoyang

  • Meizhou People's Hospital

    Meizhou

  • Jiangxi Cancer Hospital

    Nanchang

  • Huashan Hospital, Fudan University

    Shanghai

  • Liaoning Cancer Hospital & Institute

    Shenyang

  • The First Hospital of China Medical University

    Shenyang

  • The Forth Hospital of Hebei Medical University and Hebei Tumor Hospital

    Shijiazhuang

  • The Second Affiliated Hospital of Soochow University

    Suzhou

  • Hubei Cancer Hospital

    Wuhan

  • Tongji Hospital Tongji Medical College of HUST

    Wuhan

  • The First Affiliated Hospital of Xiamen University

    Xiamen

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

Official title: An Open-Label, Phase 1, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CMG901 in Subjects With Advanced Unresectable or Metastatic Solid Tumor

This is a multi-center, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of CMG901.

The dose escalation phase (Part A) will determine the MTD of CMG901 in subjects with relapsed and/or refractory advanced solid tumor for which there is no available standard therapy likely to confer clinical benefit, or the subject is not a candidate for such available therapy based on a modified 3+3 dose escalation design (an accelerated dose titration design followed by traditional 3+3 dose escalation design).

The dose expansion phase (Part B) will be conducted in subjects with advanced solid cancer with failure of standard treatment or no standard treatment who are Claudin 18.2 positive to preliminarily explore the efficacy and to determine the RP2D of CMG901.

Being tested
CMG901
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CMG901Drug

    CMG901 will be administered intravenously (IV) on Day 1 of every 21-day cycle. Individual subjects may continue study treatment until confirmed Progressive Disease(PD), unacceptable toxicity, initiation of new anti-tumor therapy, withdrawal from the study, or death, whichever occurs first.

Study groups in NCT04805307
Study groupRoleWhat they receive
Part A, Dose escalationExperimentalCMG901 will be administered in treatment cycles once every 3 weeks (Q3W). Dose escalation will be carried out according to a modified 3+3 dose-escalation design. Accelerated dose titration design will be used for the first 2 dose levels (0.3mg/kg and 0.6mg/kg), and then traditional 3+3 dose escalation design will be used for the following levels (1.2mg/kg, 1.8mg/kg, 2.2mg/kg, 2.6mg/kg and 3.0mg/kg).
Receives: Drug: CMG901
Part B, Dose expansion,2.2mg/kgExperimentalThis cohort will comprise subjects with Claudin 18.2 positive gastric cancer (including gastroesophageal junction adenocarcinoma), pancreatic cancer, and other solid cancer with prior failure of, progression on, or intolerance to, standard therapy.
Receives: Drug: CMG901
art B, Dose expansion,3.0mg/kgExperimentalThis cohort will comprise subjects with Claudin 18.2 positive gastric cancer (including gastroesophageal junction adenocarcinoma), pancreatic cancer, and other solid cancer with prior failure of, progression on, or intolerance to, standard therapy.
Receives: Drug: CMG901
Part B, Dose expansion,3.0mg/kgExperimentalThis cohort will comprise subjects with Claudin 18.2 positive gastric cancer (including gastroesophageal junction adenocarcinoma), pancreatic cancer, and other solid cancer with prior failure of, progression on, or intolerance to, standard therapy.
Receives: Drug: CMG901

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Incidence of adverse events.Abnormal laboratory parameters, vital signs, 12-lead electrocardiogram and physical examination. Occurrence of Dose-limiting toxicity

    Measured: Up to 30 days post the last dose, initiation of new anti-tumor therapy, withdrawal from the study, or death, whichever occurs first. DLTs are up to 21 days after the first dose

  2. Part A: To determine the maximum tolerated dose (MTD) of CMG901

    Measured: Up to 21 days after the first dose

  3. Part B: To preliminarily evaluate the Objective Response Rate (ORR) per RECIST v1.1 of CMG901 in subjects with Claudin 18.2-positive advanced solid cancer

    Measured: Up to 24 months

  4. Part B: Recommended phase II dose

    Measured: Up to 24 months

Secondary outcomes (29)

  1. Part A & Part B: Area Under the Curve from 0 to the time of the last measurable concentration [AUC(0-last)]

    Measured: 21 days after the first dose

  2. Part A & Part B: Area Under the Curve over a dosing interval [AUC(0-tau)]

    Measured: 21 days after the first dose

  3. Part A & Part B: Area Under the Curve from 0 to infinity [AUC(0-inf)]

    Measured: 21 days after the first dose

  4. Part A & Part B: Peak Plasma Concentration (Cmax)

    Measured: 21 days after the first dose

  5. Part A & Part B: Time of Maximum Observed Concentration (Tmax)

    Measured: 21 days after the first dose

  6. Part A & Part B: Terminal elimination half-life (t1/2)

    Measured: 21 days after the first dose

  7. Part A & Part B: Clearance (CL)

    Measured: 21 days after the first dose

  8. Part A & Part B: Volume of distribution (Vz)

    Measured: 21 days after the first dose

  9. Part A & Part B: Observed concentration at the end of a dosing interval(Ctrough)

    Measured: 21 days after the first dose

  10. Part A & Part B: Area Under the Curve from 0 to the time of the last measurable concentration [AUC(0-last)]

    Measured: up to 24 months

  11. Part A & Part B: Area Under the Curve over a dosing interval [AUC(0-tau)]

    Measured: up to 24 months

  12. Part A & Part B: Peak Plasma Concentration (Cmax)

    Measured: up to 24 months

  13. Time of maximum observed concentration (Tmax)

    Measured: up to 24 months

  14. Part A & Part B: Terminal elimination half-life (t1/2)

    Measured: up to 24 months

  15. Part A & Part B: Clearance (CL)

    Measured: up to 24 months

  16. Part A & Part B: Volume of distribution (Vz)

    Measured: up to 24 months

  17. Part A & Part B: Volume of distribution at steady-state (Vss)

    Measured: up to 24 months

  18. Part A & Part B: Minimum concentration (Cmin)

    Measured: up to 24 months

  19. Part A & Part B: Observed concentration at the end of a dosing interval (Ctrough)

    Measured: up to 24 months

  20. Part A & Part B: Accumulation ratios of peak plasma concentration (Cmax) for multiple doses

    Measured: up to 24 months

  21. Part A & Part B: Accumulation ratios of area under the curve over a dosing interval [AUC(0-tau)] for multiple doses

    Measured: up to 24 months

  22. Part A & Part B: Incidence of anti-CMG901

    Measured: up to 24 months

  23. Part A & Part B: Disease Control Rate (DCR) per RECIST v1.1

    Measured: up to 24 months

  24. Part A & Part B: Duration of Response (DoR) per RECIST v1.1

    Measured: up to 24 months

  25. Part A & Part B: Progression Free Survival (PFS) per RECIST v1.1

    Measured: up to 24 months

  26. Part A&B:To evaluate the correlation between clinical efficacy of CMG901 and Claudin 18.2 expression

    Measured: up to 24 months

  27. Part A: Objective Response Rate (ORR) per RECIST v1.1

    Measured: up to 24 months

  28. Part A & Part B: Overall Survival (OS)

    Measured: up to 24 months

  29. Part B: Incidence of adverse events graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Abnormal laboratory parameters, vital signs, 12-lead electrocardiogram and physical examination

    Measured: Up to 30 days post the last dose, initiation of new anti-tumor therapy, withdrawal from the study, or death, whichever occurs first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2021
  2. Study start24 Dec 2020
  3. Primary completion5 Apr 2024
  4. Study completion5 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Part A：Dose Escalation: Modified 3+3 dose escalation design: an accelerated dose titration design followed by traditional 3+3 dose escalation design. Part B：Dose Expansion: Subjects will be enrolled at 2.2 mg/kg, 2.6 mg/kg, 3.0 mg/kg and/or other higher dose levels.
Masking
None (open label)
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04805307
Sponsor's protocol ID
KYM901
Status last verified
Feb 2025
First submitted
16 Mar 2021
Last updated
12 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ruan DY, Liu FR, Wei XL, Luo SX, Zhuang ZX, Wang ZN, Liu FN, Zhang YQ, Yang JW, Chen ZD, Wang YS, Wang JY, Liang XH, Wu XJ, Zheng YL, Liu J, Shi X, Kumar R, Liu W, Chen B, Zhang DS, Xu RH. Claudin 18.2-targeting antibody-drug conjugate CMG901 in patients with advanced gastric or gastro-oesophageal junction cancer (KYM901): a multicentre, open-label, single-arm, phase 1 trial. Lancet Oncol. 2025 Feb;26(2):227-238. doi: 10.1016/S1470-2045(24)00636-3. Epub 2025 Jan 6.

    PubMed 39788133

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CMG901 in people with Advanced Solid Tumor and Gastric Cancer(Including Gastroesophageal Junction Adenocarcinoma), run by Keymed Biosciences Co.Ltd at 32 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Incidence of adverse events.Abnormal laboratory parameters, vital signs, 12-lead electrocardiogram and physical examination. Occurrence of Dose-limiting toxicity (time frame: Up to 30 days post the last dose, initiation of new anti-tumor therapy, withdrawal from the study, or death, whichever occurs first. DLTs are up to 21 days after the first dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04805307, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.

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